Device product

LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

Z-2037-2023

May 02, 2023

Class II

Product summary

Firm: Implant Direct Sybron Manufacturing LLC
Event: Event 92415
Status: Ongoing
Classification: Class II
Quantity: 29
Official record key: device-enforcement:Z-2037-2023

Official wording

Reason: Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

Code information: REF/UDI-DI/Lot: 8730-81NE/10841307123002/92637, 131309; 8730-82NE/10841307123019/92638, 163063; 8735-80NNE/10841307123026/160542; 8735-82NE/10841307123064/15002360; 8745-80NNE/10841307123033/15004780; 8745-82NE/10841307123071/182029;

Distribution pattern: US Nationwide distribution in the states of FL, ID, TX, CA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.